Quality Assurance Associate
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling, and final kitting of reagents and consumables. In July of 2018, Argonaut acquired LyoGen, a leader in dose-specific lyophilization capabilities for the diagnostics markets. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Position and Scope
Argonaut Manufacturing Services has an immediate opening for a Quality Assurance Associate. The role will be responsible for releasing batch records, creating and revising technical documents (including SOPs, specifications, reports, etc.), as well as driving the resolution of product quality customer complaints and internal non-conformance events. The position will also be responsible for supporting customer and external audits to satisfactory outcomes, performing root cause analysis and other problem-solving activities to identify CAPA and process improvements.
The individual will also support the QA department in ensuring that audit findings are addressed and resolved, addressing non-conformances in manufacturing, implementing and performing document control and change control procedures, CAPA, tracking, and trending. The position will report to the Director of Quality Assurance. We offer a competitive salary, benefits, and equity participation.
We are looking for an energetic, hands-on knowledgeable problem solver. Working knowledge of the following skills:
- eQMS systems including MasterControl
- Strong written and verbal skills required
- Experience in Life Science QA in a cGMP and ISO13485 production environment required
- Good documentation practices necessary
- Strong interpersonal skills and the ability to work with and lead cross-functional teams under strict timelines
- Excellent problem solving / troubleshooting skills and the ability to analyze and interpret data to make business-critical decisions
- Attention to detail and disciplined in execution
- Strong initiative and willingness to take ownership and drive projects to completion
- Ability to work independently and also in a team-based environment effectively
- Ability to create and revise manufacturing documentation, processing documents, SOPs, manufacturing pilot plans, etc.
- Capable of serving as a subject matter expert for manufacturing during varied audits by customers and regulatory bodies
- Advise the manager of factors that may affect the quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA)
- BS/BA preferred. Three years’ experience in a QA role required, preferably with a medical device company.
- Hands-on experience in QA/QC required with participation in audits (performing, conducting, participating) with large Life Science of medical device company
- Proven knowledge in process validation
- Excellent written and verbal communication skills
- Ability to communicate effectively with people in other disciplines
- Organized, responsible, dependable with an ability to work in a team environment
- Knowledge in lab space layout and design from a Lean Manufacturing perspective a plus
- Experience following standard operating procedures and recording data extemporaneously in batch documentation while following good documentation practices
(Nice to have to support manufacturing)
- Experienced in the use LIMS for manufacturing applications
- Experiences with product transfers or new product implementations
- ERP implementation and operational experience
- Working knowledge of 5S and Lean Manufacturing Principles
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
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